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Title
Text copied to clipboard!CMC Officer
Description
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We are looking for a dedicated and experienced CMC Officer to join our team. The CMC Officer will be responsible for overseeing and managing all Chemistry, Manufacturing, and Controls (CMC) activities within our organization. This role is critical in ensuring that our products meet the highest standards of quality, safety, and efficacy. The ideal candidate will have a strong background in pharmaceutical sciences, regulatory affairs, and project management. They will work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure that all CMC activities are aligned with regulatory requirements and company goals. The CMC Officer will also be responsible for preparing and reviewing CMC documentation for regulatory submissions, managing timelines and budgets, and ensuring that all CMC activities are conducted in compliance with Good Manufacturing Practices (GMP) and other relevant guidelines. This role requires excellent communication and leadership skills, as well as the ability to work in a fast-paced and dynamic environment. If you are passionate about ensuring the quality and safety of pharmaceutical products and have the skills and experience required for this role, we would love to hear from you.
Responsibilities
Text copied to clipboard!- Oversee and manage all CMC activities within the organization.
- Ensure compliance with regulatory requirements and guidelines.
- Prepare and review CMC documentation for regulatory submissions.
- Collaborate with cross-functional teams to ensure alignment of CMC activities.
- Manage timelines and budgets for CMC projects.
- Ensure compliance with Good Manufacturing Practices (GMP).
- Conduct risk assessments and implement mitigation strategies.
- Monitor and report on the progress of CMC activities.
- Provide technical support and guidance to team members.
- Develop and implement CMC strategies and plans.
- Ensure the quality, safety, and efficacy of products.
- Conduct audits and inspections of manufacturing facilities.
- Review and approve batch records and other manufacturing documentation.
- Ensure proper documentation and record-keeping of CMC activities.
- Stay updated on regulatory changes and industry trends.
- Train and mentor junior staff members.
- Participate in regulatory inspections and audits.
- Develop and maintain relationships with external partners and stakeholders.
- Ensure continuous improvement of CMC processes.
- Resolve any issues or challenges related to CMC activities.
Requirements
Text copied to clipboard!- Bachelor's degree in Pharmaceutical Sciences, Chemistry, or a related field.
- Minimum of 5 years of experience in CMC or a related role.
- Strong knowledge of regulatory requirements and guidelines.
- Experience with regulatory submissions and documentation.
- Excellent project management skills.
- Strong communication and leadership skills.
- Ability to work in a fast-paced and dynamic environment.
- Experience with Good Manufacturing Practices (GMP).
- Strong analytical and problem-solving skills.
- Attention to detail and accuracy.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office and other relevant software.
- Experience with risk assessment and mitigation.
- Strong organizational and time management skills.
- Ability to manage multiple projects and priorities.
- Experience with audits and inspections.
- Knowledge of pharmaceutical manufacturing processes.
- Ability to develop and implement CMC strategies.
- Strong technical writing skills.
- Commitment to continuous improvement and professional development.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with CMC activities?
- How do you ensure compliance with regulatory requirements?
- Can you provide an example of a successful CMC project you managed?
- How do you handle challenges or issues related to CMC activities?
- What is your experience with regulatory submissions and documentation?
- How do you stay updated on regulatory changes and industry trends?
- Can you describe your experience with Good Manufacturing Practices (GMP)?
- How do you manage timelines and budgets for CMC projects?
- What strategies do you use to ensure the quality and safety of products?
- How do you collaborate with cross-functional teams?
- Can you describe a time when you had to conduct a risk assessment?
- How do you ensure proper documentation and record-keeping of CMC activities?
- What is your experience with audits and inspections?
- How do you develop and implement CMC strategies?
- Can you describe your experience with pharmaceutical manufacturing processes?
- How do you provide technical support and guidance to team members?
- What is your approach to continuous improvement of CMC processes?
- How do you resolve issues or challenges related to CMC activities?
- Can you describe your experience with training and mentoring junior staff members?
- How do you develop and maintain relationships with external partners and stakeholders?
